메뉴 건너뛰기




Volumn 18, Issue 3, 2008, Pages 483-493

On power and sample size calculation for QT studies with recording replicates at given time point

Author keywords

Correlation coefficient; Crossover design; Measurement error; Parallel group design; QT Studies

Indexed keywords

AB INITIO CALCULATION; ARTICLE; CORRELATION COEFFICIENT; CROSSOVER PROCEDURE; ELECTROCARDIOGRAM; PRIORITY JOURNAL; QT INTERVAL; ANALYSIS OF VARIANCE; CHEMICALLY INDUCED DISORDER; DRUG EFFECT; ELECTROCARDIOGRAPHY; HEART RATE; HUMAN; LONG QT SYNDROME; METHODOLOGY; PATHOPHYSIOLOGY; PHYSIOLOGY; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; STATISTICAL MODEL; STATISTICS;

EID: 45849089186     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400801995452     Document Type: Article
Times cited : (19)

References (11)
  • 1
    • 38549156747 scopus 로고    scopus 로고
    • Exact tests for negligible interaction in two-way linear models
    • Cheng, B., Shao, J. (2007). Exact tests for negligible interaction in two-way linear models. Statistica Sinica 17:1441-1455.
    • (2007) Statistica Sinica , vol.17 , pp. 1441-1455
    • Cheng, B.1    Shao, J.2
  • 4
    • 45949092140 scopus 로고    scopus 로고
    • FDA/TPD (2003). Preliminary concept paper: The clinical evaluation of QT/QTc interval prolongation and proarrythmic potential for non-arrythmic drug products. Released on November 15, 2002. Revised on February 6, 2003.
    • FDA/TPD (2003). Preliminary concept paper: The clinical evaluation of QT/QTc interval prolongation and proarrythmic potential for non-arrythmic drug products. Released on November 15, 2002. Revised on February 6, 2003.
  • 5
    • 45949102663 scopus 로고    scopus 로고
    • ICH E14 Guidance on the Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential for Non-Antiarrythmic Drugs. Geneva
    • ICH , May
    • ICH (2005). ICH E14 Guidance on the Clinical Evaluation of QT/QTc Interval Prolongation and Proarrythmic Potential for Non-Antiarrythmic Drugs. Geneva, Switzerland: International Conference on Harmonisation, May 2005.
    • (2005) Switzerland: International Conference on Harmonisation
  • 7
    • 0035021986 scopus 로고    scopus 로고
    • Evaluation of drug-induced QT interval prolongation
    • Malik, M., Camm, A. J. (2001). Evaluation of drug-induced QT interval prolongation. Drug Safety 24:323-351.
    • (2001) Drug Safety , vol.24 , pp. 323-351
    • Malik, M.1    Camm, A.J.2
  • 8
    • 0027296372 scopus 로고
    • Measurement of the QT interval and the risk associated with QT interval prolongation
    • Moss, A. J. (1993). Measurement of the QT interval and the risk associated with QT interval prolongation. American Journal of Cardiology 72:23B-25B.
    • (1993) American Journal of Cardiology , vol.72
    • Moss, A.J.1
  • 9
    • 45949105022 scopus 로고    scopus 로고
    • Investigating drug-induced QT and QTc prolongation in the clinic: Statistical design and analysis considerations
    • PhRMA , August 14
    • PhRMA (2003). Investigating drug-induced QT and QTc prolongation in the clinic: Statistical design and analysis considerations. Report from the Pharmaceutical Research and Manufacturers of America QT Statistics Expert Team, August 14, 2003.
    • (2003) Report from the Pharmaceutical Research and Manufacturers of America QT Statistics Expert Team
  • 10
    • 45949083490 scopus 로고    scopus 로고
    • Assessing the effects of replicate ECGs on QT variability in healthy subjects
    • Presented at
    • Strieter, D., Wu, W., Agin, M. (2003). Assessing the effects of replicate ECGs on QT variability in healthy subjects. Presented at Midwest Biopharmaceutical Workshop, May 21, 2003.
    • (2003) Midwest Biopharmaceutical Workshop, May 21
    • Strieter, D.1    Wu, W.2    Agin, M.3
  • 11
    • 45949098378 scopus 로고    scopus 로고
    • Overview of the concept paper, history of the QT/TdP concern; regulatory implications of QT prolongation
    • Available at
    • Temple, R. (2003). Overview of the concept paper, history of the QT/TdP concern; regulatory implications of QT prolongation. Presentations at Drug Information Agency/FDA Workshop. Available at: www.diahome.org.
    • (2003) Presentations at Drug Information Agency/FDA Workshop
    • Temple, R.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.